BHIC Guidance

Sammons BrainHealth Imaging Center at The University of Texas at Dallas (UTD) MRI & IRB Review / Approval Process for Non-UTD Users

Below is guidance for non-UTD users to request approval to conduct research at the Sammons BrainHealth Imaging Center at UTD (“BHIC”).

Before you start, it is important to note both of the following items:

• IRB approval at your institution must be obtained prior to submitting the application for review / approval at UTD. A copy of your institution’s IRB approval documents (approval letter, protocol, consent forms, etc.) are required attachments during the submission process; and
• The appropriate UTD Committee approvals (outlined in items 4 – 6 below) must be obtained prior to conducting any research procedures at UTD.

1. MRI Service Agreement (Facility Use Agreement / Inter-Institutional Agreement)

1. A Facility Use Agreement (“the Agreement”) or Inter-Institutional Agreement (“IIA”) must be completed between UTD and the non-UTD institution that plans to use the BHIC to conduct their research.  This step should be completed before beginning the review / approval process outlined below.

2. If your institution has not entered into the Agreement or IIA (or if you are unsure), please contact Brian Scott in the Office of Technology Commercialization.

3. Center Use Application. Once the non-UTD institution has completed the Agreement or IIA, each new study / project will require a Center Use Application (Exhibit C of the Agreement) submitted to the BHIC for review.

2. UTD NetID Account

1. A UTD NetID account is required to access Cayuse (IRB electronic submission portal). BHIC personnel (Administrative Coordinator) will assist in requesting a UTD NetID account for the non-UTD PI and study team (such as a Research Assistant or Lab Manager) who will provide assistance during the submission process via Cayuse.
2. The UTD NetID account can be requested by emailing Angela Plata with the following information for each individual that will need an account:
   1. Name
   2. Email address
   3. Work address
   4. Date of birth
3. Once a NetID account has been assigned, users will receive an email with instructions to finalize the account setup.

3. Cayuse Account

Once a NetID account has been finalized, the PI and all users who will provide assistance with the application submission process will need to request a Cayuse account.  The request can be submitted via the following link: Cayuse Account Request.  Please allow 1-3 business days for processing.

4. Cayuse Application

1. An application can be submitted by clicking on the blue New Study button and selecting the Initial option via Cayuse. Resources on the submission process are available and may be useful: Cayuse Resources.
2. Select the MRI Service Agreement (Non-UTD Personnel) option in the Submission Information section and complete the application.
3. Once the application has been completed, a checkmark should appear for each section on the left side of the page. Click Complete Submission to submit the application. The non-UTD PI must certify the application before it can be submitted.
4. Once the application has been submitted, the Human Subjects Research (HSR) Office will work with the non-UTD PI and study team during the pre-review process to ensure the protection of human participants involved in the procedures conducted at UTD before the application is submitted for MRI review / approval.
5. Cayuse communications / notices are sent to the UTD email account ONLY.  Non-UTD personnel are responsible for logging into Cayuse and/or their UTD email account to receive notices regarding their application status.

5. UTD MRI Safety & Feasibility Committee Review / Approval

1. Once the HSR pre-review process has been completed, the UTD MRI Safety & Feasibility Committee will review the submission and work with the non-UTD PI and study team during this process.
2. Once MRI approval has been obtained, the application will be routed to the HSR Office.
3. Non-UTD personnel are responsible for reviewing the BHIC MRI Safety Policies and Procedures Manual and MRI Screening Form which can be found on the BHIC website.

6. UTD Human Subjects Research Review / Determination

1. Once the MRI Safety & Feasibility Committee has provided approval for the MRI procedures, the HSR Office will review and release a determination letter documenting that UTD is not engaged in the research procedures.
2. After the HSR determination letter has been released, the research procedures may be conducted in accordance with the approved protocol.

7. Post Approval

1. It is the responsibility of the non-UTD PI to submit a Modification request via Cayuse if any changes are needed for the MRI procedures conducted at the BHIC.
2. Once all procedures have concluded at the BHIC, it is the responsibility of the non-UTD PI to submit a Closure request via Cayuse.

For questions related to the BHIC or the MRI review / approval process, please contact Angela Plata at Angela.Plata@utdallas.edu.

For questions related to Cayuse or the HSR review / determination process, please contact the HSR Office at HSR@utdallas.edu.